Recall alert: Losartan potassium tablets recall expanded
Torrent Pharmaceuticals Limited has expanded its recall of Losartan potassium tablets USP. Originally the company recalled 10 lots of the medication. Now company officials have added an additional six lots of Losartan potassium and hydrochlorothiazide tablets after trace amounts of N-nitrosodiethylamine (NDEA) was found in one of the pill's active ingredients, the Food and Drug Administration announced.
NDEA is a naturally occuring substance that is found in some food, water, air pollution and industrial processes. It has been classified as a probable human carcinogen.
The recall only affects products that have more than the acceptable amount of NDEA, according to the FDA.
Patients on the recalled pills are being instructed to continue taking them until they contact their doctor or pharmacist for an alternative treatment, the FDA said in its press release.
The following tablets are covered by the Torrent Pharmaceuticals recall:
- LOSARTAN POTASSIUM TAB, USP 100mg, 30-count bottles, NDC number 13668-115-30, Lot BO31C016, expiration date 04/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg, 90-count bottles, NDC number 13668-115-90, Lot BO31C016, expiration date 04/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg, 1000-count bottles, NDC number 13668-115-10, Lot 4DK3C005, expiration date 4/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg, 1000-count bottles, NDC number 13668-115-10, Lot 4DK3C004, expiration date 4/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg, 1000-count bottles, NDC number 13668-115-10, Lot 4DU3C040, expiration date 10/2019.
- LOSARTAN POTASSIUM TAB, USP 100mg, 1000-count bottles, NDC number 13668-115-10, Lot 4DU3E049, expiration date 5/2021.
- LOSARTAN POTASSIUM TAB, USP 100mg, 1000-count bottles, NDC number 13668-115-10, Lot 4DU3E050, expiration date 5/2021.
- LOSARTAN POTASSIUM TAB, USP 50mg, 30-count bottles, NDC number 13668-409-30, Lot 4L67C035, expiration date 10/2019.
- LOSARTAN POTASSIUM TAB, USP 50mg, 90-count bottles, NDC number 13668-409-90, Lot 4L67C035, expiration date 10/2019.
- LOSARTAN POTASSIUM TAB, USP 50mg, 90-count bottles, NDC number 13668-409-90, Lot 4L67C036, expiration date 10/2019
- LOSARTAN POTASSIUM TAB, USP 50mg, 1000-count bottles, NDC number 13668-409-10, Lot 4O50C005, expiration date 11/2019.
- LOSARTAN POTASSIUM TAB, USP 25mg, 90-count bottles, NDC number 13668-113-90, Lot 4O49C013, expiration date 9/2019.
- LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 50mg/12.5 mg, 90-count bottles, NDC number 13668-116-90, Lot BP02C008, expiration date 3/2019.
- LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 50mg/12.5 mg, 1000 count bottles, NDC number 13668-116-10, Lot BEF7D006, expiration date 3/2020.
- LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 100 mg/12.5 mg, 90-count bottles, NDC number 13668-117-90, Lot BX35C020, expiration date 5/2019.
- LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 100 mg/12.5 mg, 90-count bottles, NDC number 13668-117-90, Lot BX35C049, expiration date 8/2019.
- LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 100 mg/12.5 mg, 1000-count bottles, NDC number 13668-117-10, Lot BX35C022, expiration date 5/2019.
- LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 100 mg/12.5 mg, 1000-count bottles, NDC number 13668-117-10, Lot BX35C023, expiration date 5/2019.
Those who may have medical questions about the recall or who want to report a reaction to the medication are being directed to call 1-800-912-9561 or email medinfo.torrent@apcerls.com.
